Cost-saving analysis of screening colonoscopy in Germany.

BACKGROUND: Screening colonoscopy was introduced into the National Cancer Prevention Program in Germany in 2002. We have explored costs and savings of screening and surveillance colonoscopy to investigate whether the induced savings may compensate for the costs of screening. METHODS: The study design was a model calculation based on data of a large-scale documentation of screening colonoscopy. The costs and savings of screening colonoscopy were evaluated over a defined period of 10 years. Basic data about findings, adverse effects and costs of screening colonoscopy were obtained from a large-scale online registry of 109 989 procedures and from the actual payments of procedures in Germany. Plausible baseline parameter values of the characteristics of screening and surveillance colonoscopy, of adenoma progression and recurrence, and of costs for diagnosis and treatment of colorectal cancer were based on available data. The impact of major model assumptions was evaluated by sensitivity analyses. RESULTS: A programme based on one-time screening colonoscopy could result in net savings over a period of 10 years in Germany due to avoidance of cancer treatment costs compensating for the costs of screening, surveillance and adverse effects. Average net savings from euro 121 to euro 623 per screenee could be achieved according to our model assuming different progression and recurrence rates of adenomas and carcinoma costs from euro 21 820 to euro 40 000. LIMITATIONS: For some major model parameters assumptions had to be derived from the literature. CONCLUSIONS: This analysis based on empirical data from the nationwide screening colonoscopy programme in Germany suggests net savings resulting from colorectal cancer prevention that compensate for the costs of screening and surveillance.

Propofol sedation in outpatient colonoscopy by trained practice nurses supervised by the gastroenterologist: a prospective evaluation of over 3000 cases.

BACKGROUND AND STUDY AIMS: Propofol has several advantages for sedation in endoscopic procedures. Sedation administered by anaesthesiologists is associated with high costs. In this study the safety of propofol sedation administered by trained practice nurses under the supervision of the gastroenterologist in a cohort of outpatients of an ambulatory practice for gastroenterology in Germany is evaluated. METHODS: During a period of 21 months all patients referred to colonoscopy were eligible for this prospective observational study. The familiar CRC risk of the individuals, indication, completeness and results of the colonoscopy were registered together with the dose of propofol used. Propofol was administered by intermittent intravenous bolus titration by trained practice nurses under supervision of the gastroenterologist. Oxygen saturation, heart rate and blood pressure were recorded constantly during the procedure and adverse cardiopulmonary events were monitored by the endoscopy team. A respiratory event was defined as an episode of apnoea or laryngospasm requiring assisted ventilation. 23 % of the patients received supplemental oxygen. RESULTS: A total of 3641 colonoscopies were recorded. 33 individuals were sedated with midazolam and were excluded from the evaluation. 3610 individuals were sedated with propofol (119 +/- 39 mg, mean dose +/- S. D.). 40 % of the procedures were performed as combined gastroscopy and colonoscopy. The cecum was reached in 99 % of the colonoscopies. Respiratory events occurred in five patients (0.14 %). Assisted ventilation in all cases was performed by mask ventilation. Bradycardia (HF < 60/min) and arterial hypotension (RR < 90 mmHg) occurred in 0.5 and 0.3 % of the colonoscopies, respectively, but medical intervention was necessary only in 0.2 % for both types of event. Minor events of hypoxaemia were observed in 51 patients (1.4 %), but only 1/3 of these events occurred in patients supplemented with oxygen. CONCLUSIONS: Propofol can be administered safely for ambulatory colonoscopy by trained practice nurses, with careful monitoring under supervision of the gastroenterologist.

[Results of coloscopy screening in 2005--an Internet-based documentation]. / Ergebnisse der Vorsorge-Koloskopie 2005--Internet-basierte Dokumentation.

BACKGROUND AND OBJECTIVE: In October 2002 screening coloscopy was introduced into the National Cancer Prevention Programme in Germany. The results of an online registry are presented here. METHODS: Data from consecutive screening colonoscopies in the practices of the 280 participating gastroenterologists, performed in asymptomatic subjects, were collected in an online registry. Number and histology of colorectal polyps and carcinomas, complication rates of colonoscopy and polypectomy were registered. Advanced adenoma was defined as an adenoma >10 mm in diameter, with villous or tubulovillous histology, or presence of high-grade dysplasia. RESULTS: A total of 109989 colonoscopies (43% in males) were evaluated from October 2003 to July 2005. Tubular and villous adenomas were found in 16.2% and 3.8%, respectively, whereas invasive cancers were diagnosed in 0.7%. Advanced adenomas amounted to 6.1%.The majority of carcinomas were detected in early stages (UICC stages I and II in 48 and 22 %, respectively). -In most of the polyps immediate polypectomy was carried out. The complication rate was low and no deaths were observed: cardiopulmonary complications occurred in 0.10% of the colonoscopies, bleeding in 0.79% of polypectomies most of which were managed endoscopically (surgery in 0.04% of polypectomies). Perforation occurred in 0.02% of the colonoscopies and 0.10% of polypectomies. CONCLUSIONS: Neoplasias of the colon were detected in about 20% of persons who had taken part in a colonoscopy screening programme: most of the lesions were immediately removed by polypectomy. The high rate of early stages of colorectal cancers detected by screening colonoscopy is an indirect indicator of mortality reduction. In Germany screening colonoscopy has a low risk.

Band erosion with gastric cancer.

Adjustable gastric banding is a well-established procedure for the treatment of morbid obesity. We present a 62-year-old female who experienced the rare complication of intragastric band perforation due to a gastric adenocarcinoma localized at the site of gastric banding, 10 years after insertion of the band.

[Screening colonoscopy among persons 50 to 60 years of age with and without familial risk of colorectal cancer - a prospective multicenter trial]. / Screeningkoloskopie bei Personen zwischen 50 und 60 Jahren mit und ohne familiäres Risiko für Kolonkarzinom - eine prospektive Multizenterstudie.

BACKGROUND: In Germany screening colonoscopy was introduced into the National program on colorectal cancer prevention in Oktober 2002. The prevalence of neoplasia in patients with and without familiar risk was determined together with patient satisfaction with screening colonoscopy. METHODS: Asymptomatic subjects from 50 to 60 years underwent screening colonoscopy and were stratified in two groups with and without familiar risk (first-degree relatives with CRC) in a multicenter trial among German gastroenterologists. Advanced neoplasia was defined as an adenoma at least 1 cm in diameter, a villous adenoma, an adenoma with high-grade dysplasia, or invasive cancer. After recovery from sedation all subjects were asked if they would agree to a control colonoscopy and the pain score was recorded on a scale from 0 to 6. RESULTS: A total of 557 subjects (322 at average risk and 235 with familiar risk) underwent screening colonoscopy. The prevalence of advanced neoplasia in subjects without/with familiar risk was not significantly different in persons from 50 to 54 years (9 vs. 15 %) in contrast to persons from 55 to 60 years (10 vs. 22 %, p = 0.004) where the relative risk was doubled. Compared to younger patients, the prevalence of all neoplasia (including small adenomas) was significantly different only for older patients with familiar risk (44 vs. 23 %, p < 0.0001). The mean value of the pain-score was 0.76 + 1.0. Subjects examined without medication had significantly higher pain scores than subjects under medication. Colonoscopy performed under disoprivan resulted in similar pain-scores compared to midazolam at dosages > 5 mg. All patients agreed to a control colonoscopy. CONCLUSION: Screening colonoscopy is an effective and well-accepted method. The high prevalence of advanced neoplasia even in persons from 50 to 54 years suggests that screening should start at the age of 50.

Prospective evaluation of complications in outpatient GI endoscopy: a survey among German gastroenterologists.

BACKGROUND: Although most diagnostic GI endoscopic procedures in Germany are performed on an outpatient basis, there is no large-scale prospective evaluation of complication rates. METHODS: Ninety-four gastroenterologists and internists from all regions of Germany recorded the number of EGD, colonoscopies, and polypectomies performed over a period of 1 year. All serious complications occurring in relation to the procedure, including the use of medication, were recorded in a structured protocol. RESULTS: A total of 110,469 EGDs, 82,416 colonoscopies, and 14,249 polypectomies were evaluated. The "reach-the-cecum-rate" was 97% (median). The overall complication rates for EGD, colonoscopy, and polypectomy were low compared with published data (0.009%, 0.02%, and 0.36%, respectively). The perforation rates were 0.0009%, 0.005%, and 0.06%, respectively, the rates of significant hemorrhage 0.002%, 0.001%, and 0.26%, respectively, and the mortality rates 0.0009%, 0.001%, and 0.007%, respectively. The rates of cardiorespiratory complications associated with EGD and colonoscopy were 0.005% and 0.01%, respectively. The overall complication rate for all procedures (diagnostic and therapeutic) was lower for gastroenterologists (1 per 5155 procedures) than internists (1 per 1539 procedures). Most of the adverse events associated with diagnostic endoscopy were attributable to use of medication. The severity score ranged from 2 to 5 for most of the adverse events occurring as a result of diagnostic procedures and 2 to 50 for polypectomy. The severity sum score per 10,000 procedures was 26 for EGD, 67 for colonoscopy, and 1185 for polypectomy. CONCLUSIONS: Outpatient endoscopy performed in practice settings by German gastroenterologists and internists is safe. The low complication rates may partly be explained by the high degree of experience resulting from the larger numbers of procedures performed relative to the numbers performed by gastroenterologists in hospitals and in other countries.

[How safe is premedication in ambulatory endoscopy in Germany? A prospective study in gastroenterology specialty practices]. / Wie sicher ist die Prämedikation in der ambulanten Endoskopie in Deutschland? Eine prospektive Untersuchung in gastroenterologischen Fachpraxen.

BACKGROUND: To date there is no prospective large-scale study of the risk of premedication on the complication rate of outpatient gastrointestinal endoscopy in Germany. PATIENTS AND METHODS: In 67 gastroenterological practises in Germany the number of esophagogastroduodenoscopies (EGD) and colonoscopies was recorded from april 1998 until march 1999. All serious complications had to be recorded in a structured protocol. RESULTS: The overall complication rate for EGD (n = 110,469) was low (0.009%) and about two third of the adverse effects were due to premedication (0.006%). The overall complication rate for diagnostic colonoscopy (n = 82,416) was 0.02% and the complication rate associated to premedication was 0.01%. An individual dosage of premedication for EGD and colonoscopy was given by all gastroenterologists. Most of the gastroenterologists applied premedication in 10 to 50 percent of the patients for EGD and in 70 to 100 percent of the patients for colonoscopy. Most of the cardiorespiratory adverse effects in colonoscopy occurred if sedation was performed by combination of benzodiazepines and opioids and in upper gastrointestinal endoscopy with high dosages of diazepam. In 6 of 45 practises disoprivan (propofol) was used for premedication in 2-50 percent of the colonoscopies. Two of four perforations in diagnostic colonoscopy occurred under sedation with disoprivan. CONCLUSIONS: Outpatient gastrointestinal endoscopy performed by German gastroenterologists in a safe. The complication rate is low compared to the international literature and could be further decreased by avoiding a combination of benzodiazepines and opioids for sedation in colonoscopy and high dosages of diazepam in upper gastrointestinal endoscopy.

Helicobacter pylori vacA genotypes and cagA gene in a series of 383 H. pylori-positive patients.

BACKGROUND: Only 10-15% of all patients infected with Helicobacter pylori develop peptic ulcer disease (PUD) or gastric cancer. Apart from immunological factors in the host, virulence determinants of H. pylori such as the vacuolating cytotoxin (VacA) or the cytotoxin-associated protein A (CagA) might represent a predisposition for the development of PUD. METHODS: We studied antral biopsies of 383 H. pylori-positive patients with peptic ulcer disease (PUD) or other H. pylori-related diseases for H. pylori vacA genotypes and the presence of the cagA gene by PCR. RESULTS: VacA genotypes and cagA status could be completely determined in 357 (93.2%) of the patients. In 91 (93.8%) of 97 patients with PUD, the vacA s1 genotype (s1m1, 45; s1m2, 46 patients) was present. The vacA s2m2 genotype was found in only 6 (6.2%) of 97 patients with PUD. In contrast, 180 (75.3%) of 239 patients (s1m1, 89; s1m2, 91 patients) without PUD and without gastric malignancies harbored strains with the vacA s1 genotype. The vacA genotype s2m2 was found in 59 (24.7%) of these patients. The presence of the cagA gene was closely associated with the vacA genotype s1 and found in 124 (88.6%) and in 113 (80.7%) of patients with the s1m1 or s1m2 genotypes, respectively, whereas strains with the genotype s2m2 were almost exclusively cagA negative. CONCLUSION: Most H. pylori strains found in patients with PUD possess the vacA s1 genotype and the cagA gene. Patients with this type of H. pylori strain but without PUD might be at higher risk of developing PUD. In contrast, the risk for PUD might be significantly decreased in those patients who are infected by H. pylori strains with the vacA s2 genotype lacking the cagA gene.

Short-term triple therapy with lansoprazole 30 mg or 60 mg, amoxycillin and clarithromycin to eradicate Helicobacter pylori.

BACKGROUND: We investigated the efficacy of 30 vs. 60 mg lansoprazole daily in a 1-week triple therapy for eradication of Helicobacter pylori in a prospective randomized study. METHODS: Two hundred and fifteen consecutive out-patients with peptic ulcer disease or non-ulcer dyspepsia, in whom H. pylori infection was confirmed by histology and/or a urease biopsy test, were randomly assigned to a 1-week treatment with either 15 mg lansoprazole b.d. (LAC15 group) or 30 mg lansoprazole b.d. (LAC30 group) in combination with 1 g amoxycillin b.d. and 500 mg clarithromycin b.d. RESULTS: Eradication of H. pylori was successful in 87% (per protocol) and 82% (intention-to-treat) of the patients with LAC15 and in 94% (per protocol) and 87% (intention-to-treat) of the patients with LAC30. The difference was not significant. In both treatment groups, all peptic ulcers were healed at the check-up. Adverse effects were seen in 11 patients of the LAC15 group and 10 patients of the LAC30 group: they caused discontinuation of the therapy in four of the LAC15 group and two patients of the LAC 30 group. CONCLUSIONS: A 7-day triple therapy using lansoprazole (LAC15) is an efficient and economical regimen for the eradication of H. pylori.

Direct determination of Helicobacter pylori vacA genotypes and cagA gene in gastric biopsies and relationship to gastrointestinal diseases.

OBJECTIVE: Our aim was to detect Helicobacter pylori (H. pylori) from gastric biopsies of 248 patients using a novel, polymerase chain reaction (PCR)-based methodology, which simultaneously facilitates the determination of H. pylori vacA genotypes and cagA gene. METHODS: A simple methodology for sample preparation was established and PCR was performed with primer systems for the 16S rRNA, vacA, and cagA genes, thus circumventing the need to culture H. pylori and to extract DNA from biopsy samples. RESULTS: Infection with H. pylori was detected in 147 (59.3%) of 248 patients. The vacA signal sequence genotype s1 was present in 104 (81.3%) of 128 H. pylori-positive patients, and 24 (18.8%) patients had the genotype s2. The vacA middle region types m1 and m2 were detected in 46 (35.9%) and 79 (61.7%) patients, respectively. The combinations s1/m2 (43%) and s1/m1 (35.9%) were found more frequently than s2/m2 (18.8%). The cagA gene was detected in 75 (72.1%) of 104 H. pylori-positive biopsies with the vacA genotype s1. All 24 biopsies with the type s2 were cagA negative. Strains of the type vacA s1 were found in 97% of H. pylori-positive patients with peptic ulcer disease and were associated with the presence of the cagA gene, whereas 96% of the strains of the type vacA s2 were detected in patients who only had nonulcer dyspepsia. CONCLUSIONS: Using a novel PCR-based methodology, H. pylori 16S rRNA gene, vacA genotypes, and cagA gene can now be rapidly detected directly in gastric biopsies with high accuracy. These data demonstrate that infection with H. pylori strains of the vacA s1 genotype and the cagA gene are more likely to result in peptic ulcer disease. Determination of vacA genotypes and cagA gene may contribute to the potential clinical identification of patients at different levels of risk.

Detection of colorectal neoplasms by the highly sensitive hemoglobin-haptoglobin complex in feces.

Screening for fecal occult blood by means of guaiac tests has an unsatisfactory sensitivity for the detection of colorectal neoplasms. The immunological determination of human hemoglobin in feces has a higher sensitivity and specificity, but hemoglobin is degraded during its transport through the gastrointestinal tract. We compared the hemoglobin test to a newly developed immuno-chemiluminometric (ILMA) assay for quantifying the hemoglobin-haptoglobin complex in feces which shows high stability against degradation. From each of 621 patients with gastrointestinal complaints before scheduled colonoscopy we collected two 1-ml samples from a single stool; there were no dietary restrictions. The sensitivity for detecting colorectal carcinomas proved 87% with hemoglobin. With the hemoglobin-haptoglobin complex it was 87% at a cutoff level of 1.5 microg/g feces, 83% at 2.0 microg/g feces, and 78% at 2.5 and 3.0 microg/g feces. The sensitivity for detecting large adenomatous polyps was 54% with hemoglobin, 76% with the hemoglobin-haptoglobin complex at a cutoff point of 1.5 microg/g feces, 73% with the hemoglobin-haptoglobin complex at 2.0 and 2.5 microg/g feces, and 65% with the hemoglobin-haptoglobin complex at 3.0 microg/g feces. The optimal cutoff point for the hemoglobin-haptoglobin complex was estimated to be 2.0 microg/g stool. The specificity for hemoglobin (99%) was significantly higher than that for the hemoglobin-haptoglobin complex at 2.0 microg/g feces (96%). Immunological determination of the hemoglobin-haptoglobin complex in feces has a comparable sensitivity as the fecal hemoglobin assay for colorectal carcinomas and a significantly higher sensitivity for adenomatous polyps but a significantly lower specificity. Its use for colorectal cancer prevention is currently being evaluated in a screening study.

Screening for colorectal neoplasms with a new immunological human faecal haemoglobin and albumin test.

In Germany, screening for colorectal cancer shows low efficiency, which is partly due to demographic changes with a rising mean age of the population, a low participation rate and an unsatisfactory sensitivity of guaiac tests for detecting faecal occult-blood. Therefore, a pilot screening study with a new immunological faecal haemoglobin and albumin test was performed in Ostringen, Germany to assess its compliance, performance characteristics and cost-effectiveness. Two thousand, seven hundred and eighty-five persons (1,498 women and 1,287 men) collected 1 ml samples from two different sites of one stool. The upper limit of normal was 10 micrograms/g stool for haemoglobin and 100 micrograms/g stool for albumin. The compliance was 82%; 224 persons (8%) had a positive test result. Of these, 184 underwent full colonoscopy. We detected 14 colorectal cancers, 10 of which were Dukes' stage A carcinomas removed by endoscopic polypectomy, 34 large adenomas and 43 small adenomas. The detection rate for colorectal neoplasms was above the rate described for other immunological haemoglobin tests and for Haemoccult tests. The specificity of the test--defined with false-positive results if a normal colon mucosa and no other reasons for upper or lower gastrointestinal bleeding were found--was 99.5%. The cost-effectiveness was assessed by comparing the diagnostic costs with the savings resulting from prevention of colorectal carcinomas by endoscopic polypectomy of malignant polyps (Dukes' stage A). The savings in our screening study exceeded the diagnostic costs by approximately 2.3 times. The combined immunological faecal haemoglobin and albumin test should substitute the Haemoccult test in colorectal cancer screening because of its higher sensitivity and specificity combined with cost-effectiveness and good patient compliance.

Validity of new immunological human fecal hemoglobin and albumin tests in detecting colorectal neoplasms--an endoscopy-controlled study.

BACKGROUND: Screening for occult blood by means of guaiac tests has an unsatisfactory sensitivity for the detection of colorectal neoplasms. To increase sensitivity and specificity the immunological determination of human hemoglobin and albumin in feces has been developed. The validity of analyzing only two samples from one bowel movement of either test is not known. METHODS: An immunological determination of human fecal hemoglobin and albumin using luminescence immunoassays (LIA) was performed in 739 patients with gastrointestinal complaints before scheduled colonoscopy. Each patient collected two 1 ml samples from one stool. There were no dietary restrictions. RESULTS: The sensitivity for detecting colorectal carcinomas was 95.3% (95% confidence interval 84.2-99.4%) with hemoglobin and 67.4% (95% confidence interval 51.2-80.9%) with albumin. The sensitivity for detecting large adenomatous polyps was 62.9% (95% confidence interval 50.5-74.1%) with hemoglobin and 32.9% (95% confidence interval 22.1-45.1%) with albumin. The specificity was 97% for hemoglobin, 96% for albumin and 94% for the combined test. CONCLUSIONS: The immunological determination of fecal hemoglobin is superior to albumin and has a better sensitivity for the detection of colorectal neoplasms than that reported for guaiac tests, even if two samples from one bowel movement are examined. The immunological determination of fecal hemoglobin should therefore be evaluated for use in colorectal cancer screening.

Diversity of Helicobacter pylori vacA and cagA genes and relationship to VacA and CagA protein expression, cytotoxin production, and associated diseases.

The vacuolating cytotoxin and the cytotoxin-associated protein, encoded by vacA and cagA, respectively, are important virulence determinants of Helicobacter pylori. Sixty-five H. pylori strains were isolated from dyspeptic patients (19 with peptic ulcer disease, 43 with chronic gastritis, and 3 with gastric cancer) and studied for differences in the vacA and cagA genes and their relationship to VacA and CagA expression, cytotoxin activity, and the clinical outcome of infection. By PCR, fifty-four (83.1%) of 65 strains had the vacA signal sequence genotype s1 and only 10 (15.4%) had the type s2. After primer modification, the vacA middle-region types m1 and m2 were detected in 24 (36.9%) and 41 (63.1%) strains, respectively. The combinations s1-m2 (31 [47.7%]) and s1-m1 (23 [35.4%]) occurred more frequently than s2-m2 (10 [15.4%]) (P = 0.01). No strain with the combination s2-m1 was found. All 19 patients with peptic ulcers harbored type s1 strains, in contrast to 32 (74.4%) of 43 patients with gastritis (P = 0.02). The vacA genotype s1 was associated with the presence of cagA (P < 0.0001), VacA expression (P < 0.0001), and cytotoxin activity (P = 0.003). The cagA gene was detectable in 48 (73.8%) of 65 isolates and present in 16 (84.2%) of 19 ulcer patients and 29 (67.4%) of 43 patients with gastritis (P = 0.17). The vacA genotypes of German H. pylori isolates are identical to those previously reported. H. pylori strains of vacA type s1 are associated with the occurrence of peptic ulceration and the presence of cagA, cytotoxin activity, and VacA expression.

Elevated serum levels and reduced immunohistochemical expression of thrombomodulin in active ulcerative colitis.

BACKGROUND & AIMS: The pathogenesis of ulcerative colitis and Crohn's disease is still unclear. Vascular injury has been suggested as a potential pathogenetic mechanism. Serum thrombomodulin is a marker of endothelial cell injury. The aim of this study was to determine the relevance of increased serum thrombomodulin levels for assessing disease activity in inflammatory bowel disease. As a potential cause of serum thrombomodulin level increase, the loss of local vascular thrombomodulin expression was investigated immunohistochemically. METHODS: Thrombomodulin levels were determined by enzyme-linked immunosorbent assay in sera from patients with ulcerative colitis, Crohn's disease, Schistosoma mansoni infection, and infectious diarrhea and controls. The vascular expression of thrombomodulin was investigated immunohistochemically in fresh frozen transmural specimens of normal, Crohn's, and ulcerative colitis bowel samples. RESULTS: Significantly elevated serum thrombomodulin levels were only detected in active ulcerative colitis and infectious diarrhea complicated by septicemia. A marked and general loss of vascular endothelial cell thrombomodulin expression was found immunohistochemically in inflamed bowel tissues. Graded by a newly established thrombomodulin staining index, this was significantly more marked in ulcerative colitis than Crohn's disease. CONCLUSIONS: Serum thrombomodulin proved to be a novel marker of disease activity in ulcerative colitis closely related to local vascular endothelial cell damage, which might be a relevant pathophysiological feature of ulcerative colitis.

Solid phase competitive luminescence immunoassay for immunoglobulin A in faeces: development and clinical validation.

We describe a new simple solid-phase competitive luminescence immunoassay (LIA) for the determination of immunoglobulin A (IgA) in faeces. The assay utilizes an anti-alpha-chain IgA antibody which is coated to polystyrene beads and acridinium ester-labelled human IgA as tracer and, therefore, measures both monomeric and polymeric IgA. Dilution recovery of an internal standard was 96, 100 and 103%. Interassay and intra-assay coefficients of variation (C.V.) ranged from 4.5 to 12.9%. The upper limit of normal of faecal IgA in 122 healthy controls was found to be 300 mg/l IgA (mean 73 mg/l, specificity of 99.2%). Patients with inactive Crohn's disease (Crohn's disease activity index (CDAI < 150, n = 14) had faecal IgA values up to 3317 mg/l (mean 1073 mg/l; P < 0.0001). In the active group (CDAI > 150, n = 26) faecal IgA values ranged from 49 to 4094 mg/l (mean 1253 mg/l; P < 0.0001). Patients with ulcerative colitis were divided into a group with active disease (n = 18) and a remission group (n = 16) with values up to 1843 mg/l faecal IgA (man 486 mg/l; P < 0.0032) and up to 602 mg/l faecal IgA (mean 176 mg/l; P < 0.4833), respectively. We also studied patients with non-inflammatory diseases of the gut with this assay. This LIA has proved to be a reliable method for the determination of elevated faecal IgA concentrations and for the detection of pathological findings in the gastrointestinal tract, especially in Crohn's disease.